FDA Inspection
Reichert, Inc.Reichert, Inc. – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns Reichert, Inc., with an inspection on April 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ef1878ec-52b3-446e-b31d-bfec2ae52f9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010616
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Reichert, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Reichert, Inc.
- FDA Inspection 754500 - 2011-11-22
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